Public Assessment Report

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1 Public Assessment Report Decentralised Procedure Alendronic Acid and Calcium/Cholecalciferol mg/880IU Film-coated Tablets+Effervescent Tablets Procedure No: UK Licence No: PL 04416/ Sandoz Limited

2 LAY SUMMARY On 21 March 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorisations to Sandoz Limited for the medicinal products Alendronic Acid and Calcium Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets (PL 04416/1162-4; ). These medicines are only available on prescription from your doctor and are used to treat osteoporosis in women after menopause who also need daily calcium and vitamin D 3 supplementation. This combination medicine reduces the risk of spinal and hip fractures. Alendronic Acid and Calcium Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets contain the active substances alendronic acid and calcium/cholecalciferol. Alendronic acid belongs to a group of medicines called bisphosphonates. It prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. Calcium/cholecalciferol provides the calcium and the vitamin D 3 that the body may need to harden new bone. No new or unexpected safety concerns arose from these applications and it was therefore judged that the benefits of taking Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets outweigh the risks and Marketing Authorisations were granted. 2

3 TABLE OF CONTENTS Module 1: Information about initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Patient Information Leaflet Page 6 Module 4: Labelling Page 7 Module 5: Scientific discussion Page 14 I Introduction II About the product III Scientific overview and discussion III 1 Quality aspects III 2 Non-clinical aspects III 3 Clinical aspects IV Overall conclusion and benefit/risk assessment Module 6: Steps taken after initial procedure Page 24 3

4 Module 1 Information about the initial procedure Product Name Alendronic Acid 70 mg Tablets plus Calcium/Cholecalciferol 1000mg/880 IU Effervescent Tablets Type of Application Known active substance, Article 8.3 Active Substances Alendronic acid, calcium carbonate and cholecalciferol Forms Strengths MA Holder Reference Member State (RMS) Concerned Member States (CMS) Film-coated tablets + effervescent tablets Film-coated tablet: 70 mg alendronic acid (as mg sodium alendronate trihydrate). Procedure Number Timetable Day January 2013 Effervescent tablet: 2500 mg calcium carbonate (equivalent to 1000 mg calcium) and 22 micrograms (880 IU) cholecalciferol (vitamin D3). Sandoz Limited Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR United Kingdom UK UK/H/4113/01/DC: Belgium, Germany, Luxembourg, Romania and Slovenia. UK/H/4114/01/DC: Germany UK/H/4115/01/DC: Germany UK/H/4113-5/01/DC 4

5 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 5

6 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 6

7 Module 4 Labelling Please note the representative labelling text for Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets (PL 04416/1164; UK/H/4115/001/DC) is show below. The labelling text details for Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets (PL 04416/1162-3; UK/H/4113-4/001/DC) are consistent with this text, with the exception of the Marketing Authorisation number. The MAH has submitted a text version only and has committed to submitting mock-up livery to the relevant regulatory authorities for approval before packs are marketed. 7

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14 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the member states considered that the applications for Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets (PL 04416/1162-4; ) could be approved. The products are prescription-only medicines (POM) indicated for the treatment of post-menopausal osteoporosis, to reduce the risk of vertebral and hip fractures. Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets are only intended for use in assessed patients for whom the amount of calcium and vitamin D 3 included is considered to provide adequate supplementation. The applications were submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS), and Belgium, Germany, Luxembourg, Romania and Slovenia as Concerned Member States (CMS) in one of the procedures and Germany as the only CMS in the other two procedures. The applications were submitted under Article 8(3) of Directive 2001/83/EC, as amended, as known active substances. These applications concern a combination pack, consisting of two components, Alendronic Acid 70 mg film-coated tablets and effervescent tablets containing 2500 mg calcium carbonate (corresponding to 1000 mg elemental calcium) and 880 IU cholecalciferol (corresponding to 22 μg vitamin D 3 ). The separate medicinal products are packed together in a single carton and under a single Marketing Authorisation number. The purpose of this combination pack is to improve patient compliance to dosing instructions. Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Alendronate decreases bone turnover leading to progressive gains in bone mass. Alendronic acid is pharmacologically inactive when incorporated in bone matrix. Calcium carbonate is commonly used as a calcium supplement. Cholecalciferol (Vitamin D 3 ) belongs to the pharmacological class of vitamins. The administration of calcium/cholecalciferol in combination with any bisphosphonate in osteoporosis is to avoid secondary hyperparathyroidism and to ensure sufficient availability of calcium for the mineralisation of the bone matrix. No new non-clinical studies were performed, which is acceptable given that the pharmacodynamic, pharmacokinetic and toxicological properties of alendronate sodium, calcium carbonate and cholecalciferol are well-known. The applicant has provided an adequate non-clinical overview. The applicant has submitted mixed applications with a referenced clinical overview for alendronate, calcium carbonate and cholecalciferol. The applications for calcium carbonate/cholecalciferol are based on well-established use; no new clinical studies have been performed. In addition, to support the alendronate component of the applications, one single-dose, bioequivalence study was submitted comparing the applicant s test product Alendronate 70 mg film-coated tablet and the reference product Fosamax 70 mg film-coated tablets (Merck Sharp & Dohme, Germany). The bioequivalence study has already been accepted in the EU for the purposes of authorisation of alendronate Sandoz 70 mg film-coated tablets (SE/H/704-6/01/DC) in The bioequivalence study was carried out in accordance with Good Clinical Practice (GCP) and the Declaration of Helsinki. 14

15 The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place at all sites responsible for the manufacture, assembly and batch release of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. The RMS and CMS considered that the applications could be approved at the end of procedure (Day 210) on 16 January After a subsequent national phase, licences were granted in the UK on 21 March II. ABOUT THE PRODUCT Name of the products in the Reference Member State Name(s) of the active substance(s) (INN) Pharmacotherapeutic classification (ATC code) Pharmaceutical forms and strengths Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets Alendronic acid and Calcium carbonate/cholecalciferol Drugs affecting bone structure and mineralisation, Bisphosphonates, combinations (ATC code: M05BB05) Film-coated tablet: 70 mg alendronic acid (as mg sodium alendronate trihydrate). Effervescent tablet: 2500 mg calcium carbonate (equivalent to 1000 mg calcium) and 22 micrograms (880 IU) cholecalciferol (vitamin D 3 ). Reference numbers for the Decentralised Procedure Reference Member State (RMS) United Kingdom Concerned Member States (CMS) UK/H/4113/001/DC: Belgium, Germany, Luxembourg, Romania and Slovenia UK/H/4114/001/DC: Germany UK/H/4115/001/DC: Germany Marketing Authorisation Numbers PL 04416/ Name and address of the authorisation holder Sandoz Limited Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. United Kingdom III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS ACTIVE SUBSTANCE SODIUM ALENDRONATE INN: Alendronate sodium Chemical name: (4-amino-1-hydroxybutylidene)bisphosponic acid monosodium salt trihydrate Structure: Molecular formula: C 4 H 12 NNaO 7 P 2,3H 2 O 15

16 Molecular weight: Appearance: A white or almost white, crystalline powder. Solubility Soluble in water, very slightly soluble in methanol and practically insoluble in methylene chloride. Sodium alendronate is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance sodium alendronate are either covered by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability or by information provided by the relevant active substance supplier. In cases where an EDQM certificate is not available, synthesis of the active substance from the designated starting materials has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents and these are supported by relevant Certificates of Analysis. Appropriate proof-of-structure data have been supplied. All potential known impurities have been identified and characterised. An appropriate specification is provided for the active substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Batch analysis data are provided and comply with the proposed specification. Satisfactory Certificates of Analysis have been provided for all working standards. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with foodstuff. Appropriate stability data have been generated to support a suitable retest period when stored in the proposed packaging. ACTIVE SUBSTANCE CALCIUM CARBONATE INN: Calcium carbonate Molecular Formula: CaCO 3 Structure Ca 2+ (CO 3 ) 2- Molecular weight: g/mol Appearance: A white or almost white powder. Solubility Practically insoluble in water, its solubility in water is increased by the presence of carbon dioxide ammonium salts, practically insoluble in alcohol, soluble with effervescence in acetic acid, hydrochloric acid and nitric acid, soluble in methylene chloride and methanol and sparingly soluble in ethanol (96 %). Calcium carbonate is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance calcium carbonate are covered by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability. ACTIVE SUBSTANCE CHOLECALCIFEROL CONCENTRATE (POWDER FORM) INN: Cholecalciferol Ph.Eur Cholecalciferol concentrate (powder form) Chemical Name: (5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3β-ol Molecular Formula: C 27 H 44 O 4 16

17 Structure Molecular weight: Appearance: A white or almost white crystal. Solubility Practically insoluble in water and is freely soluble in alcohol, chloroform and fatty acid. Cholecalciferol concentrate (powder form) is the subject of a European Pharmacopoeia monograph. Synthesis of the active substance from the designated starting materials has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents and these are supported by relevant Certificates of Analysis. Appropriate proof-of-structure data have been supplied. All potential known impurities have been identified and characterised. An appropriate specification is provided for the active substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Batch analysis data are provided and comply with the proposed specification. Satisfactory Certificates of Analysis have been provided for all working standards. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with foodstuff. Appropriate stability data have been generated to support a suitable retest period when stored in the proposed packaging. MEDICINAL PRODUCT Other Ingredient Other ingredients consist of the pharmaceutical excipients in the alendronic acid film-coated tablet and the calcium carbonate/cholecalciferol effervescent tablets namely: Film-coated tablet - microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, carrageenan and Macrogol 8000 Effervescent tablet - anhydrous citric acid, simeticone, gelatin, lactose monohydrate, macrogol 6000, maize starch, methylcellulose, sodium cyclamate, sodium hydrogen carbonate, Povidone K25, saccharin sodium hydrogenated soya-bean oil, sucrose, alpha-tocopherol and Orange juice flavour (PHS ). Appropriate justification for the inclusion of each excipient has been provided. With the exception of carrageenan and Orange juice flavour (PHS ), all excipients comply with their respective European Pharmacopoeia monographs. Carrageenan complies with United States National Formulary specifications and Orange juice flavour (PHS ) complies with a suitable in-house specification. Certificates of Analysis have been provided for all excipients, showing compliance with the proposed specification. 17

18 With the exception of lactose monohydrate and gelatin, none of the excipients contain materials of animal or human origin. The suppliers of lactose monohydrate have confirmed that the milk used in the production of the lactose monohydrate is sourced from healthy animals under the same conditions as that intended for human consumption. In addition, the suppliers have confirmed that no ruminant material other than calf rennet is used during the production of lactose monohydrate. The supplier of gelatin has provided a Certificate of Suitability from the European Directorate for the Quality of Medicines (EDQM) to show that it is manufactured in line with current European guidelines concerning minimising the risk of transmission of Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathies (BSE/TSE). No genetically modified organisms (GMO) have been used in the preparation of these excipients. Pharmaceutical Development The objective of the development programme was to formulate a safe, efficacious, stable product comparable in performance to the innovator product Fosamax 70 mg Once Weekly Tablets (Merck, Sharp and Dohme, Germany). A satisfactory account of the pharmaceutical development has been provided. Comparative in-vitro dissolution profiles have been provided for the proposed Alendronic Acid 70 mg film-coated tablets and the innovator product Fosamax 70 mg (Merck Sharp & Dohme, Germany). Manufacturing Process Satisfactory batch formulae have been provided for the manufacture of both the alendronic acid film-coated tablets and the calcium carbonate/cholecalciferol effervescent tablets, along with appropriate accounts of the manufacturing processes. The manufacturing processes have been validated with production-scale batches and have shown satisfactory results. Control of Finished Product The finished product specifications for both the alendronic acid film-coated tablets and the calcium carbonate/cholecalciferol effervescent tablets are acceptable. Test methods have been described and have been validated adequately. Batch data have been provided and comply with the release specifications. Certificates of Analysis have been provided for all working standards used. Container-Closure System The alendronic acid film-coated tablets are packed in OPA-aluminium-polvinylchloride/aluminium blisters. The calcium carbonate/cholecalciferol effervescent tablets are packed in polypropylene tubes with polyethylene stoppers containing a silica gel desiccant. The finished product is packed in pack sizes of: 1 film-coated tablet + 6 effervescent tablets 2 film-coated tablets + 12 effervescent tablets 4 film-coated tablets + 24 (2 x 12) effervescent tablets 3 x [4 film-coated tablets + 24 (2 x 12) effervescent tablets] 4 x [4 film-coated tablets + 24 (2 x 12) effervescent tablets] 6 x [4 film-coated tablets + 24 (2 x 12) effervescent tablets] Not all pack sizes may be marketed Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. All primary packaging complies with the current European regulations (Directive 2002/72/EC, as amended) concerning materials in contact with foodstuff. 18

19 Stability of the Product Finished product stability studies were performed in accordance with current guidelines on batches of finished product in the packaging proposed for marketing. The data from these studies support a shelf-life of 3 years, with the storage conditions Do not store above 25 C. Store in the original package in order to protect from light and moisture. The shelf-life reduces to 1 month after opening for the calcium/cholecalciferol effervescent tablets. Bioequivalence/Bioavailability Satisfactory Certificates of Analysis have been provided for the test and reference batches used in the bioequivalence study. The bioequivalence study is discussed in Section III.3, Clinical Aspects. Summaries of Product Characteristics (SmPCs), Product Information Leaflet (PIL) and Labels The SmPCs, PIL and label texts are satisfactory from a pharmaceutical perspective. The Marketing Authorisation Holder (MAH) has committed to submitting mock-up livery to the relevant regulatory authorities for approval before packs are marketed. User testing of the package leaflet for Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets has been accepted based on the bridging report provided, making reference to the successful user-testing of the parent PIL for Risedronate +Calcium/Vitamin D 3 35 mg mg/880 IU film-coated and effervescent tablets authorised in the EU. Marketing Authorisation Application (MAA) Forms The MAA forms are satisfactory from a pharmaceutical perspective. Expert Report (Quality Overall Summary) The quality overall summary has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical aspects of the dossier. Conclusion The grant of Marketing Authorisations is recommended. III.2 NON-CLINICAL ASPECTS As the pharmacodynamic, pharmacokinetic and toxicological properties of alendronic acid, calcium carbonate and cholecalciferol are well-known, no new non-clinical data have been submitted and none were required. The non-clinical overview was written by an appropriately qualified person and is satisfactory, providing an appropriate review of the relevant non-clinical pharmacology, pharmacokinetics and toxicology. Suitable justification has been provided for the non-submission of an Environmental Risk Assessment. As Alendronic Acid and Calcium Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets are intended for substitution of already authorised products no change to the environmental exposure is anticipated following approval of the Marketing Authorisations for the proposed product. The grant of Marketing Authorisations is recommended. 19

20 III.3 CLINICAL ASPECTS Clinical Pharmacololgy The clinical pharmacology of alendronic acid, calcium carbonate and cholecalciferol are well-known. With the exception of data from the bioequivalence study detailed below, no new pharmacodynamic or pharmacokinetic data were provided or required for these applications. No bioequivalence studies were submitted or required for the calcium carbonate/cholecalciferol components of the applications as their authorisations are based on well-established use, which is adequately summarised and justified in the clinical overview. In support of the alendronate component of the applications, the Marketing Authorisation Holder submitted the following bioequivalence study. The submitted bioequivalence study was also part of the dossier for Alendronate 70 mg Sandoz (SE/H/704-6/01/DC), an MAA which was submitted in the EU and approved in A randomised, open-label, two-period, two-treatment single-dose crossover study comparing the rate and extent of absorption of the test product Sodium Alendronate 70 mg film-coated tablet (Lek d.d., Slovenia) and the reference product Fosamax 70 mg film-coated tablets (Merck Sharp & Dohme, Germany) in healthy male subjects under fasting conditions. Subjects were administered one tablet of either the test or the reference product with 240 ml of water, after at least a 10 hour fast. Urine sampling was performed pre-dose and up to 72 hours post dose in each treatment period. The washout period between the two treatment arms was 21 days. Pharmacokinetic parameters were measured from urine and statistically analysed. The applicant has provided satisfactory justification for the use of cumulative urinary excretion data as an acceptable surrogate for a plasma extent of absorption (AUC) concentration. The pharmacokinetic results are presented below: Pharmacokinetic parameters (arithmetic means±sd and coefficient of variation) of alendronate Alendronate Sodium Fosamax (Reference) (test) Mean±SD CV (%) Mean±SD CV (%) Ae 0-72 (μg) ± ± R max (μg/h) 97.74± ± Ae 0-72 R max SD CV Cumulative urinary excretion from zero to the time 72 hours maximum rate of urinary excretion standard deviation coefficient of variation Ae 0-72 Alendronate Sodium (Test) vs Fosamax (Reference) Ratio of Least Square Means (%) % Geometric CI Intra-Subject CV (%) Ae 0-72 CI CV Cumulative urinary excretion from zero to the time 72 hours confidence interval coefficient of variation R max Alendronate Sodium (Test) vs Fosamax (Reference) Ratio of Least Square Means (%) % Geometric CI Intra-Subject CV (%) R max CI CV maximum rate of urinary excretion confidence interval coefficient of variation 20

21 The 90 % confidence intervals of the test/reference ratio of geometric means for Ae 0-72 and R max lie within the acceptable limits of % to %. Thus, the data support the claim that the applicant s test product Sodium Alendronate 70 mg film-coated tablets is bioequivalent to the reference product Fosamax 70 mg film-coated tablets (Merck Sharp & Dohme, Germany). Efficacy The efficacy of alendronic acid, calcium carbonate and cholecalciferol is well-known. No new efficacy data have been submitted. Safety With the exception of the safety data generated during the bioequivalence study, no new safety data were submitted. No new or unexpected safety issues were raised during the bioequivalence study. Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels The SmPCs, PIL and labels are acceptable from a clinical perspective. The PIL is consistent with the details in the SmPCs and in line with the current guidance. The labelling is also in line with the current guidance. Clinical Expert Report (Clinical Overview) The clinical overview has been written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. Pharmacovigilance System and Risk Management Plan The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. The applicant has adopted the abbreviated core Risk Management Plan for bisphosphonates and atypical femoral fractures as agreed by the Pharmacovigilance Working Party, and committed to adhere to the corresponding pharmacovigilance actions. Conclusion The grant of Marketing Authorisations is recommended. IV OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The important quality characteristics of Alendronic Acid and Calcium/Cholecalciferol 70 mg mg/880 IU film-coated tablets + effervescent tablets are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. NON-CLINICAL No new non-clinical data were submitted. As the pharmacokinetics, pharmacodynamics and toxicology of alendronic acid, calcium carbonate and cholecalciferol are well-known, no additional data were required. 21

22 EFFICACY With the exception of the bioequivalence study, no new data were submitted. Bioequivalence has been demonstrated between the applicant s Sodium Alendronate 70 mg film-coated tablet (Lek d.d., Slovenia) and the reference product Fosamax 70 mg film-coated tablets (Merck Sharp & Dohme, Germany). No bioequivalence studies were submitted or required for the calcium carbonate/cholecalciferol components of the applications as their authorisations are based on the demonstration of well-established use. SAFETY With the exception of the safety data from the bioequivalence study, no new data were submitted. No new or unexpected safety concerns arose from the bioequivalence study. PRODUCT LITERATURE The SmPCs, PIL and labelling are satisfactory and in line with current guidance. BENEFIT/RISK ASSESSMENT The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with alendronic acid, calcium carbonate and cholecalciferol is considered to have demonstrated the therapeutic value of the compounds. The benefit/risk balance is therefore considered to be positive. 22

23 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 23

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